NCT02732873

Porous Tissue Regenerative Silk Scaffold for Human Meniscal Cartilage Repair

A Multicentre Study Evaluating the Treatment of Meniscal Defects With a Meniscal Repair Scaffold, FibroFix™ Meniscus

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Orthox Limited · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The REKREATE project will be an international, multi-centre, non-randomised, prospective single-arm pivotal study. All study patients will receive the FibroFix™ Meniscus scaffold following the provision of informed consent. A study period of 1 year and extended follow up period of up to 3 years is planned , to enable a thorough and complete assessment of the performance of the device when implanted to replace removed or damaged meniscal tissue in humans. The test article for this multi-centre study is the FibroFix™ Meniscus scaffold, which has been developed for repair of defects of the meniscus.

Conditions

• Repair of Meniscal Injury

Interventions

Type	Name	Description
DEVICE	FibroFix Meniscal Scaffold	FibroFix™ Meniscus scaffold is a silk derived product developed to functionally replace the excised unstable meniscus following a meniscal tear.

Timeline

• Start date: 2017-01-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2016-04-11
• Last updated: 2022-10-12